drugset / Trial / NCT06175494

A Phase 3 Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of Booster Vaccination With Recombinant COVID-19 (XBB) Trimer Protein Vaccine (Sf9 Cell)

NCT06175494

RandomizedParallel-groupQuadruple-blindPrevention

Summary

The Recombinant COVID-19 (XBB) Trimer Protein Vaccine (Sf9 Cell) developed by WestVac Biopharma Co., Ltd. is a monovalent modified vaccine designed against Omicron XBB.1.5. This is a multi-center, randomized, double-blind, placebo-controlled phase 3 clinical study with two cohorts, i.e. the immuno-bridging observational cohort and the efficacy observational cohort, aims to evaluate the efficacy, safety, and immunogenicity of booster vaccination with Recombinant COVID-19 (XBB) Trimer Protein Vaccine (Sf9 Cell) for the prevention of SARS-CoV-2 infection in a population of 18 years of age and older.

Timeline

Start
2023-12-19
Primary completion
2024-07-31
Completion
2025-01-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Recombinant COVID-19 (XBB) Trimer Protein Vaccine (Sf9 Cell) Vaccine
Comparator Recombinant COVID-19 Variant Vaccine (Sf9 Cell) Vaccine

Indications